Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and 12 of 4 21-day cycles each to further characterize safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
37
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
To determine MTD and DLT of Gemcitabine Oral formulation
MTD will be determined by study structure and DLT will be determined by definition
Time frame: During the 21-day cycle 1 treatment
AE/SAE incidences
AEs will be assessed via the CTCAE version 4.03
Time frame: Throughout treatment and 30-day follow-up (estimated average of 5 months)
Changes from baseline in clinical laboratory test (hematology, biochemistry, coagulation factors and urinalysis) results, vital sign measurements, physical examination findings, and ECG and 2D echocardiogram/multiple-gated acquisition (MUGA) scan results
Time frame: Throughout treatment and 30-day follow-up (estimated average of 5 months)
characterize the PK of D07001-F4
Time frame: cycle 0 and cycle 1 (Day -7~Day 19)
ORR(Objective Response Rate) and tumor response
Time frame: After cycle 2 and cycle 4 treatments (estimated average of 2 months and 4 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.